Effectiveness of Ranolazine on Reducing Chest Pain in Patients With Blockage But no Stents

• Status: Terminated
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine if ranolazine improves angina symptoms at 4 months compared with placebo among patients who are deferred for receiving a Percutaneous Coronary Intervention (PCI) based on the Fractional Flow Reserve (FFR) measurement.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North Florida Foundation for Research and Education
• Collaborators: Gilead Sciences; University of Florida
• Treatments: Ranolazine

Criteria

Inclusion Criteria:

• Stable patients >= 18 years of age referred for cardiac catheterization for evaluation of cardiac symptoms ( angina, fatigue, or shortness of breath)

• At least 1 indeterminate stenosis (20-80%), fractional flow reserve (FFR) >=0.8 and PCI deferred

Exclusion Criteria:

• Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) during the index procedure or anticipated within the next month

• acute coronary syndrome or cardiogenic shock

• use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole, clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)

• use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)

• liver cirrhosis

• sever renal insufficience (i.e. creatinine clearance < 30mL/min/1.73 m2)

• QTc > 500 milliseconds